Neoplasms

Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Neoplasm Metastasis

Syndrome

Dehydration

Water-Electrolyte Imbalance

Metabolic Diseases

Quality of Life

Culturally Tailored Nurse Symptom Management group (CTNSM) - participants in the CTNSM group will receive one in-person or telehealth face-to-face education session followed by a weekly telephone call and/or text message during the first 12 weeks of standard of care chemotherapy. In addition, participants can receive standard of care chemotherapy education.

Participants in the control group will only be receiving the standard of care chemotherapy education.

The Culturally Tailored Nurse-delivered telephone/text message symptom-management intervention (CTNSM) intervention is an in-person or telehealth face-to-face education session followed by a weekly telephone call and/or text message conducted for the first 12 weeks of standard of care chemotherapy .

CTNSM

Standard of Care chemotherapy education is a one-time patient education session about general treatment-related side effects patients can experience from chemotherapy and the interventions to mitigate the symptoms.

Standard of Care Chemotherapy Education

Natasha Solle, PhD

The purpose of the study is to see whether or not a telephone/ text message intervention, delivered by a registered nurse, is helpful in managing symptoms and can also prevent dehydration caused by chemotherapy treatment when given together for patients with metastatic breast, colon, lung or prostate cancer.

Culturally Tailored Nurse Coaching Study for Cancer Symptom Management

Utilizing a Culturally Tailored Nurse Coaching Intervention to Decrease Symptom Severity and Prevent Dehydration in Patients With Metastatic Cancer

MD Anderson Symptom Inventory (MDASI) is a 19 item scale with a score range from 0-10 per symptom question that measures symptom severity plus symptom interference combined to measure total symptom burden. The higher score indicates worsening of symptoms.

Incidents of unscheduled medical visits for IV hydration

The CDSES is a 10 item scale with a score range from 0-10 per symptom question that measures perceived self-efficacy. The higher score indicates better perceived self-efficacy.

The PIHS is a 12 item scale with a score range from 0-8 per question that measures symptoms self-management. The higher score indicates better symptom self-management.

Feasibility will be reported as a percentage of completed calls or text messages.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Breast (FACT-B). FACT-B has a total scoring of 0-148 with the higher scoring indicating better HRQoL.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Prostate (FACT-P). FACT-P has a total scoring of 0-156 with the higher scoring indicating better HRQoL.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Colon (FACT-C). FACT-C has a total scoring of 0-144 with the higher scoring indicating better HRQoL.

Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy -Lung Cancer (FACT-LC). FACT-LC has a total scoring of 0-144 with the higher scoring indicating better HRQoL.

Oncology Nursing Society

University of Miami

assistant research professor

Anxiety Disorders

Stress, Psychological

Behavioral Symptoms

All participants will take an online questionnaire which includes their evaluation of one of 18 different emotional support messages randomly assigned through the Qualtrics survey system. The participants answer a series of closed ended scales regarding quality of the support message, supporter's competence, amount of emotional improvement they experienced after reading the message, and likelihood to seek support from the person writing the message.

Participants will be randomly shown two versions of messages in which the last 20% of the message consists of negative statements of criticism and rate of the effectiveness of the message.

Questionnaire 1a

Participants will be randomly shown two versions of messages in which the first 20% of the message consists of negative statements of criticism and rate of the effectiveness of the message.

Questionnaire 1b

Participants will be randomly shown two versions of messages in which the last 40% of the message consists of negative statements of criticism and rate of the effectiveness of the message.

Questionnaire 2a

Participants will be randomly shown two versions of messages in which the first 40% of the message consists of negative statements of criticism and rate of the effectiveness of the message.

Questionnaire 2b

Participants will be randomly shown two versions of messages in which the last 60% of the message consists of negative statements of criticism and rate of the effectiveness of the message.

Questionnaire 3a

Participants will be randomly shown two versions of messages in which the first 60% of the message consists of negative statements of criticism and rate of the effectiveness of the message.

Questionnaire 3b

Participants will be randomly shown two versions of messages in which the last 80% of the message consists of negative statements of criticism and rate of the effectiveness of the message.

Questionnaire 4a

Participants will be randomly shown two versions of messages in which the first 80% of the message consists of negative statements of criticism and rate of the effectiveness of the message.

Questionnaire 4b

Maija Reblin, PhD

Cancer patients will be randomly shown one of 18 emotional support messages created by the research team that differ based on how much of the message consists of positive statements and how much consists of negative statements. The messages with negative statements also differ based on whether the negative statements occur at the start or end of the message. After viewing the message, participants have the opportunity to rate the effectiveness of the message, to what extent the message made them feel better, and to what extent the message affects how they view the message provider as a useful source of emotional support.

Emotional Support Messages Following a Cancer Diagnosis

Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of perceived message effectiveness.

Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of self-reports of emotional improvement.

Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of perceptions of supporter competence.

Perceptions of message effectiveness will be tested through 4 ANOVA models that will test for differences between participants who received different messages in terms of their likelihood to seek support from the supporter in the future.

San Diego State University

University of Arizona

University of Minnesota

H. Lee Moffitt Cancer Center and Research Institute

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Thyroid Nodule

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements

A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements

The video is approximately 6 1/2 minutes in length and portrays an emotionally supportive conversation between a patient and surgeon during which the surgeon discusses: the diagnosis, prognosis, available treatment options, benefits and harms of the options, and need for decision making. The surgeon speaks for the majority of the simulated visit and discusses total and hemi-thyroidectomy with the addition of emotionally supportive statements and gestures.

Emotionally Supportive Video

The video is approximately 5 minutes in length and portrays a standard conversation between a patient and surgeon during which the surgeon discusses: the diagnosis, prognosis, available treatment options, benefits and harms of the options, and need for decision making. The surgeon speaks for the majority of the simulated visit and discusses total and hemi-thyroidectomy.

Standard Video

Corrine Voils, PhD

118 adults with benign thyroid nodules who were seen at a UW Health clinic for a fine needle biopsy and do not need surgery will be enrolled and can expect to be on study for a one-time visit of up to 60 minutes. Each participant will be randomized to watch one of two videos simulating a patient-surgeon discussion about treatment options for low-risk thyroid cancer with or without emotionally supportive statements.

In this study, the investigators will test the extent to which emotionally supportive communication from a surgeon is associated with patient preference for total thyroidectomy. The investigators will conduct a hypothetical choice experiment with "analogue" patients, defined as those with a benign thyroid nodule not requiring surgery.

Baseline measures will be collected, then participants will be randomized to watch a video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer with or without emotionally supportive statements.

The investigators hypothesize that increased emotionally supportive communication by the surgeon will decrease the likelihood of patients choosing total thyroidectomy, reduce anxiety and thyroid cancer fear, and increase decisional confidence, perceived physician empathy, trust in physician, and information recall.

The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer

The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer: a Randomized Hypothetical Choice Experiment

Data collected for this study will be transferred and analyzed at the University of Michigan. After the study is completed, the de-identified, archived data may be transmitted to and stored at a data repository for use by other researchers including those outside of the study. Permission to transmit data to the University of Michigan and data repository will be included in the informed consent.

The investigators will measure which treatment participants would choose if they were the patient with thyroid cancer in the video (total thyroidectomy or lobectomy) immediately after they finish watching the video.

Decisional Confidence in treatment option is measured using a single-item 10-point Likert scale where 1 is 'not confident at all' and 10 is 'completely confident'

The STAI brief is a 6-item survey about how the participant is feeling in the moment (calm, tense, upset, relaxed, content, worried) scored on a 4 point likert scale. The total possible range of scores is 6 to 24 with higher scores indicating higher anxiety.

The adapted Thyroid Cancer Fear Scale is a 8-item survey originally designed to assess fear of breast cancer in patients undergoing cancer screening. Items are rated on a 5-point scale from strongly disagree (1) to strongly agree (5) with a total possible range of scores from 8-40 where higher scores indicate increased fear of cancer.

This 5-question instrument assesses patient perceptions of physician empathy, scored on a 7-point Likert scale ranging from 'strongly disagree' (1) to 'strongly agree' (7). Items are summed, with a max score of 35, higher values indicate a perception of more empathy.

This 5-question instrument assesses patient trust in a physician, scored on a 5-point Likert scale ranging from 'strongly disagree' (1) to 'strongly agree' (5). Responses are summed and scores are on a scale of 5 to 25, with higher values indicating more trust.

National Cancer Institute (NCI)

University of Michigan

University of Wisconsin, Madison

The current study will pose minimal risk to the participants. Although no problems or adverse events are expected, any study related adverse events will be documented and reported to the local IRB per institutional policy.

A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITH emotionally supportive statements

Emotionally Supportive Video: The video is approximately 6 1/2 minutes in length and portrays an emotionally supportive conversation between a patient and surgeon during which the surgeon discusses: the diagnosis, prognosis, available treatment options, benefits and harms of the options, and need for decision making. The surgeon speaks for the majority of the simulated visit and discusses total and hemi-thyroidectomy with the addition of emotionally supportive statements and gestures.

A video simulation of a patient-surgeon discussion about treatment options for low-risk thyroid cancer WITHOUT emotionally supportive statements

Standard Video: The video is approximately 5 minutes in length and portrays a standard conversation between a patient and surgeon during which the surgeon discusses: the diagnosis, prognosis, available treatment options, benefits and harms of the options, and need for decision making. The surgeon speaks for the majority of the simulated visit and discusses total and hemi-thyroidectomy.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Education Level

Number of Participants with Bilateral Nodules

Number of participants who self-reported that their largest nodule biopsied was in the size category indication: less than or equal to 2 cm, greater than 2 cm, or unknown (meaning that the patient did not know).

Nodule Size

Participants were asked: Before your thyroid nodule(s) was biopsied, were you experiencing any symptoms from your thyroid nodule(s)? Symptoms might include problems with your swallowing, voice, or neck pressure.

Number of Participants with Symptomatic Nodule

Hypothyroidism

Baseline information provided for analysis population.

Treatment Choice

Participant Decisional Confidence Score

Baseline

Post-Intervention

State Trait Anxiety Inventory Brief (STAI Brief) Score

baseline

Adapted Thyroid Cancer Fear Scale Score

Adapted Jefferson Scale of Patient's Perceptions of Physician's Empathy Score

Adapted Trust in Physician Scale Score

Overall Study

Burnout, Psychological

Caregiver Burden

Participants assigned to this arm will be able to attend the online peer program upon entering the study.

Participants assigned to this arm will be on a waitlist and will be invited to join the online peer program in 3 months.

Online group peer program where participants learn evidence based skills for managing stressors and emotions related to their cancer experience.

Cancer Connect Program

Cecilia M Votta, PhD

Cynthia Neben, PhD

Cancer has a psychological, emotional and social impact beyond a patient's physical health. This study examines three new online peer mental-wellness support program for cancer patients, survivors or their caregivers. Each program teaches evidence-based skills, in the context of that groups lived experience, to manage the emotional impact of cancer. This study examines the impact of that program.

Cancer has a psychological, emotional and social impact beyond a patient's physical health. These problems often ripple beyond the individual with the diagnosis, to their broader community, and also beyond a cancer treatment course into survivorship. As a result, there are a wide range of socioemotional needs in those who have been impacted by cancer. Further, these emotional impacts have a direct impact on morbidity and mortality of cancer. A new peer mental-wellness support program, called Color Cancer Connect (CCC) supports cancer patients, survivors and their caregivers by teaching them evidence-based skills to manage the emotional impact of cancer. This study will examine all three programs (i.e., patient, survivor, caregiver) to gather data to measure the impact of the program on emotional well-being, quality of life and health behaviors.

Participants will be randomized to waitlist or intervention group. Those in intervention group will receive the peer program; those on the waitlist will receive it after being on the waitlist for 3 months.

Participants will be notified of a waitlist assignment upon enrolling. Those on the waitlist will receive the intervention after 3 months.

Building Empowerment and Coping Outcomes for caNcer Patients, Survivors and Their Caregivers

BEACON Study: Virtual Coping Skills Groups for Cancer Patients, Survivors and Their Caregivers

Patients: EORTC Core Quality of Life (CLC-C30), Survivors: Quality of Life Adult Cancer Survivors (QLACS), Caregivers: WHO Quality of Life Scale (WHO-QOL)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Culturally Tailored Nurse Coaching Study for Cancer Symptom Management	NCT04874584	Dehydration Symptom Cluster Quality of Life Self Efficacy Chemotherapy Ef...	CTNSM Standard of Car...	18 Years -	University of Miami
Emotional Support Messages Following a Cancer Diagnosis	NCT03840109	Psychological S... Anxiety	Questionnaire 1... Questionnaire 1... Questionnaire 2... Questionnaire 2... Questionnaire 3... Questionnaire 3... Questionnaire 4... Questionnaire 4...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
The Effect of Surgeon Emotional Support on Treatment Choice for Low-risk Thyroid Cancer	NCT05132478	Thyroid Cancer Thyroid Nodule Benign Thyroid ...	Emotionally Sup... Standard Video	18 Years -	University of Wisconsin, Madison
Building Empowerment and Coping Outcomes for caNcer Patients, Survivors and Their Caregivers	NCT06353178	Cancer Caregiving Stre... Caregiver Burno... Survivorship	Cancer Connect ...	18 Years -	Color Health, Inc.

Spots Global Cancer Trial Database for emotional support